MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER

Catalog Number 320-46-03

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision of shoulder components due to loosening.

Manufacturer Narrative

Pending evaluation.Updated with device information and index surgery date.Mdr is associated with 1038671-2018-00270.

Event Description

Revision of shoulder components due to loosening.

Event Description

The revision surgery was related to a post traumatic event, the patient was lifting a 50 lb bag of mulch.Associated mfrs for this event: 1038671-2018-00270.

Manufacturer Narrative

It is noted in the ifu that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.There is no indication that there is a device related problem/malfunction.The most likely cause of the reported event is related to patient weight and strenuous activity.Correction, no device evaluation to be performed.This device is used for treatment, not diagnosis.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: EQUINOXE REVERSE HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7296047
• MDR Text Key: 100915808
• Report Number: 1038671-2018-00211
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/03/2020
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 11/30/2018
• Supplement Dates FDA Received: 04/01/2018; 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 156